SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Prochlorperazine Maleate 3 mg Buccal Tablets

2    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Each buccal tablet contains Prochlorperazine Maleate Ph Eur 3 mg.

It also contains 48.09mg Sucrose.

For list of excipients refer 6.1

3    PHARMACEUTICAL FORM

Buccal tablet

Pale yellow to yellow, circular, biconvex uncoated tablets debossed with “P3” on one side and plain on the other side.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Treatment of nausea and vomiting in case of previously diagnosed migraine, in adults aged 18 years and over.

4.2    Posology and method of administration

To be placed in the buccal cavity, high up along the top gum under the upper lip, until dissolved. Do not chew or swallow the tablet.

Duration of treatment: Two days maximum.

Adults aged 18 years and over: One or two Prochlorperazine 3 mg Buccal Tablets twice a day. Maximum Daily dose 12mg Children under 18 years: Not recommended.

Elderly patients: There is no evidence that dosage need be modified for the elderly.

Prochlorperazine Maleate 3mg Buccal Tablet is contraindicated in patients with impaired liver function, existing blood dyscrasias, epilepsy, Parkinsons Disease, prostatic hypertrophy, narrow angle glaucoma and known hypersensitivity to the active ingredient or any of the ingredients of this product. In pregnancy.

4.4 Special warnings and precautions for use

Only use when migraine has previously been diagnosed by a doctor. Hypotension, usually postural, may occur, particularly in elderly or volume depleted patients. Tardive dyskinesia may occur occasionally, although this is normally associated with higher doses than are recommended for Prochlorperazine Maleate 3mg Buccal Tablets. Nausea and vomiting as a sign of organic disease may be masked by the antiemetic action of Prochlorperazine Maleate 3mg Buccal Tablets.

Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs. Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with Prochlorperazine Maleate 3mg Buccal Tablets and preventive measures undertaken.

Increased Mortality in Elderly people with Dementia

Data from two large observational studies showed that elderly people with dementia who are treated with antipsychotics are at a small increased risk of death compared with those who are not treated. There are insufficient data to give a firm estimate of the precise magnitude of the risk and the cause of the increased risk is not known.

Prochlorperazine Maleate 3mg Buccal Tablet is not licensed for the treatment of dementia-related behavioural disturbances.

Prochlorperazine Maleate 3mg buccal Tablets contain Sucrose.

Hyperglycaemia or intolerance to glucose has been reported in patients treated with antipsychotic phenothiazines. Patients with an established diagnosis of diabetes mellitus or with risk factors for the development of diabetes, who are started on Prochlorperazine Maleate, should get appropriate glycaemic monitoring during treatment (see section 4.8).

Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

Alcohol and CNS depressants should be used with caution- possible additive effect. Tricyclic antidepressants and antimuscarinic agents - possible enhanced antimuscarinic effect in the elderly although the risk is small. Oral anticoagulants -may have diminished effect. Thiazide diuretics - possible enhanced hypotensive effect. Propoanolol - levels of both drugs may increase. Anticonvulsants - efficacy

may be diminished necessitating dosage adjustment. Alpha-adrenoreceptor blocking antihypertensives - levels of both drugs may change. The concomitant use of lithium may result in severe extrapyrimidal side effects or severe neurotoxicity. The concurrent use of desferrioxamine and prochlorperazine should be avoided. Prochlorperazine opposes the effects of levadopa.

4.6 Pregnancy and lactation

Contraindicated in pregnancy.

Neonates exposed to antipsychotics (including prochlorperazine) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. Consequently, newborns should be monitored carefully.

Since data from animal studies shows that prochlorperazine may be found in breast milk Prochlorperazine Maleate 3mg Buccal Tablets should not be used during lactation.

4.7 Effects on ability to drive and use machines

Patients who drive or operate machinery should be warned of the possibility of drowsiness

4.8 Undesirable effects

Drowsiness, dizziness, dry mouth, insomnia, agitation and mild skin reactions may occur. Extrapyramidal reactions are very unlikely at the recommended dosage. Other effects which have occurred rarely with prochlorperazine and other phenothiazine neuroleptics include jaundice, blood dyscrasias and, very rarely, hyperprolactinaemic effects such as gynaecomastia. Neuroleptic malignant syndrome (hyperthermia, rigidity, autonomic dysfunction and altered consciousness) may occur with any neuroleptic. Use of Prochlorperazine Maleate 3mg Buccal Tablets may occasionally result in local irritation to the gum and mouth.

Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotic drugs-Frequency unknown.

System Organ Class    : Pregnancy, puerperium and perinatal

conditions

Adverse Drug Reaction/ frequency : Drug withdrawal syndrome neonatal ( see

section 4.6) / unknown

Intolerance to glucose, hyperglycaemia (see section 4.4)

The signs and symptoms will be predominantly extrapyramidal and may be accompanied either by restlessness and agitation or central nervous depression. Hypotension may also occur. Treatment is essentially symptomatic and supportive. There is no specific antidote. Gastric lavage is helpful, particularly when carried out within 6 hours of ingestion. Do not induce vomiting. Particular attention must be directed to maintaining a clear airway since this may be threatened by extrapyramidal muscle dystonias. Severe dystonic reactions usually respond to procyclidine (5-10 mg) or orphenadrine (20-40 mg) given i.m. or i.v. If convulsions occur they should be treated using i.v. diazepam. If hypotension is present, strict attention to ventilation and posturing of the patient will often secure the desired effect, but failing this, consideration should be given to volume expansion by i.v. fluids. If this is insufficient, positive inotropic agents such as dopamine may be tried, but peripheral vasoconstrictor agents are not generally recommended. Adrenaline should NOT be used

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antipsychotics, ATC code: N05AB04

Prochlorperazine is a member of the phenothiazine group of neuroleptics which, in doses lower than those used in psychiatry, is usually employed for its anti-emetic properties. The site of action is thought to be the chemoreceptor trigger zone.

5.2 Pharmacokinetic properties

Prochlorperazine Maleate 3mg Buccal Tablets are placed in the buccal cavity where they form a gel from which the prochlorperazine is released and absorbed. The plasma levels achieved at steady-state on a dosage regimen of one Prochlorperazine Maleate 3mg Buccal Tablets twice daily are similar to those observed with the standard oral dosage of one 5 mg tablet taken three times daily. The elimination halflife of prochlorperazine in this formulation is 9.0 hours, similar to that observed with the oral formulation.

5.3 Preclinical safety data

No preclinical findings of relevance have been reported

6 PHARMACEUTICAL PARTICULARS

List of excipients

Sucrose

Povidone (K-30)

Riboflavin Sodium Phosphate Xanthan Gum (FF)

Talc

Magnesium Stearate

6.2    Incompatibilities

None

6.3    Shelf life

2 years

6.4    Special precautions for storage

Store below 25°C, Store in Original Package

6.5    Nature and contents of container

Tablets are packed in an Alu/PVC/PVdC blisters Pack Size: Blister pack of 8 tablets

6.6    Special precautions for disposal

To be placed in the buccal cavity, high up along the top gum under the upper lip, until dissolved. Do not chew or swallow the tablet.

7    MARKETING AUTHORISATION HOLDER

Medreich Plc Warwick House Plane Tree Crescent

Feltham TW13 7HF

8    MARKETING AUTHORISATION NUMBER(S)

PL 21880/0126

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

09/07/2013

10    DATE OF REVISION OF THE TEXT

05/02/2014